Heretofore, percutaneous endoscopic gastrostomy (PEG) as one of endoscopic operations for forming a fistula in the lumen of the stomach and on the skin surface of the abdominal wall using an endoscope was developed as a method of, in particular, enteral nutrition by Gaudert, a kid surgeon and Ponsky, an endoscopic sergeon in 1979 (refer to, for example, patent document 1), and further several procedures making use of it have been developed and are becoming widespread respectively. However, since the stomach wall and the abdominal wall are punctured, PEG cannot be used in “cases with a large amount of ascitic retention”, “cases in which the liver and the transverse colon are present between the stomach and the adnominal wall”, “cases with a past history of stomach surgery”, and the like.
Further, although there is also a method of nasogastically indwelling a tube in the stomach, when it is indwelled therein for a long period, pain is strongly felt by the nasal passages, the nasal cavities, and the pharynx, and an ulcer is formed in the nasal passages, which makes it difficult to continuously indwell the tube. Further, there is even a case in which pneumonia is superinduced because it is difficult to eliminate sputum. PEG is also not preferable from the view point of these QOLs.
Further, Nakano et al developed a method of forming a cervical esophagus fistula under the X-ray clairvoyance in 1993. An indwelling method is such that a tube with a balloon is nasogastrically inserted in the esophagus, barium meal is injected into the balloon in the cervical esophagus, and the lumen of the cervical esophagus is expanded. Then, the cervical esophagus is endermically punctured under the X-ray clairvoyance to thereby form a cervical esophagus fistula, and a nutrition tube is indwelled therein. The indwelling method is simple, a patient is less invaded and pained, and the forming method is effective to a long-term nutrition management. However, since puncturing is executed only under the X-ray clairvoyance, there is a possibility of danger from the view point of the anatomical structure of the neck. Further, since the tube with the balloon uses a Foley catheter, whether or not a puncturing needle reaches the lumen of the esophagus when punctured is determined by that the balloon bursts. Thus, a worry arises in that the wall of the esophagus may be damaged by the extreme end of the needle after the balloon bursts and that since the puncturing needle is punctured shallow, it may be removed from the wall of the esophagus.
In contrast, Ohishi et al, who are the inventors of the present invention, improved the method of forming the cervical esophagus fistula under the X-ray clairvoyance of Nakano et al and devised a method of safely and reliably puncturing the balloon of a balloon catheter by a puncturing needle while confirming the position of the balloon from the outside of the body using an ultrasonic probe (refer to, for example, non-patent documents 1 and 2). However, this method also employs a Foley catheter likewise Nakano et al and still has a worry in that the wall of the esophagus may be damaged by the extreme end of a puncturing needle after the balloon bursts and that the needle may be removed from the wall of the esophagus.
To cope with the problem, the inventors of the present invention further improved the method of forming the cervical esophagus fistula and intended to form the cervical esophagus fistula at a bedside by composing the balloon of a balloon catheter to be punctured of a balloon which does not burst even it is punctured and combining the balloon with a dedicated introduction tool (refer to, for example, patent document 2) without using an X-ray apparatus and an endoscope. However, it could not be perfectly omitted to use the X-ray apparatus in minute manipulations such as a manipulation for eliminating a guide wire from the balloon catheter, and the like.    [Patent document] Japanese National-Publication-of-translated-version No. 6-503243    [Patent document 2] Pamphlet of International Publication No. 99/36120    [Non-patent document 1] Ohishi “Percutaneous endoscopic gastrostomy and its application and usefulness”    [Non-patent document 2] Ohishi “Percutaneous endoscopic gastrostomy and its knacks and related injuries”